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Friday, April 08, 2016

Vermillion this month published a clinical study detailing Overa's performance in the American Journal of Obstetrics and Gynecology and
now plans to begin offering the test through an early-access program
designed to generate additional performance, outcome, and health
economic data, Vermillion President and CEO Valerie Palmieri said on a
conference call this week following release of the company's Q4 and
full-year 2015 earnings results.
One of the key areas in which Overa improves upon OVA1 is specificity and positive predictive value, which have proven a stumbling block for the first-generation test. In the AJOG
study, the test distinguished between benign and malignant masses with
specificity of 69 percent and positive predictive value of 40 percent,
compared to 54 percent specificity and PPV of 31 percent for OVA1.The sensitivity and negative predictive value of the two tests, meanwhile, were equivalent.
"We
had very strong negative predictive value with OVA1, but marginal
positive predictive value, and now we have a test that has both,"
Palmieri said on this week's call.As Laura Havrilesky, a
gynecologic oncologist at Duke University, explained to GenomeWeb in a
2011 interview, low specificity was an issue for OVA1 in that it meant
the test was identifying likely benign patients as likely malignant,
which, in turn, meant Ob-Gyns were passing patients on to gynecologic
oncologists for surgeries that they could have done themselves.
"Looking
at those [specificity] numbers, if you were sitting in your general
Ob-Gyn practice, they might be a little concerning – 'A lot of my benign
cases are going to go out the door because I'm doing this test on
everybody,'" she said.
Another area in which Overa improves over
OVA1 is by eliminating the need for doctors to assess a patient's
menopausal status. OVA1 uses different cut-offs for pre- and
post-menopausal women, which, Donald Munroe, Vermillion's chief
scientific officer, said had been an issue with some doctors concerned
about using the test in patients with ambiguous menopausal status.
Additionally,
Munroe noted that the test, which replaces two of the five OVA1
biomarkers with HE4 and FSH, was designed to run on a single, integrated
platform, the Roche Cobas 6000. This is in contrast to OVA1, which ran
on two different platforms. Munroe suggested that the move to the Roche
platform would help with international clients and large reference labs.
Palmieri
said Vermillion has applied for a Category 1 Current Procedural
Terminology code from the American Medical Association for Overa and
launched an early-access program, through which institutions can begin
using the test. According to Munroe, Vermillion will select early-access
users based on a variety of criteria, including "their commercial
appeal, institutional prestige, and commitment to accelerating clinical
utility publications and local guidelines."
Munroe added that Vermillion plans to submit around six publications on the test to peer-reviewed journals this year.
As
the company rolls out Overa, it is also working to boost OVA1 sales,
which were down 19 percent in 2015 to 13,598 from 16,839 in 2014. Of the
13,598 tests performed in 2015, 8,937 were done by Quest and 4,661 were
performed by Vermillion's Aspira Labs subsidiary. The company
attributed the decline in volume to the process of transferring testing
from Quest to Aspira, with Eric Schoen, the company's chief account
officer, noting that as a new billing entity separate from Quest, the
company was experiencing claim denials and delays on tests.
"The
payor contracts did not come over with the Quest specimens, so Aspira is
in the process of obtaining its own payor contracts," he said, adding
that this would affect the timing with which Vermillion recognized test
revenue.
The company ended its licensing agreement with Quest as
part of a plan to improve its fortunes by bringing sales in house to
gain better control of the process. Management believed that, as just
one test in Quest's large catalog of offerings, OVA1 was not
consistently getting the attention and support needed to drive adoption
of such a new, highly complex diagnostic.
Increased attention to its own internal sales efforts, including a tripling
of its internal sales staff in 2014, did little to drive sales of OVA1,
however. And, in fact, on this week's earnings call, Palmieri indicated
that Vermillion was moving again to outsource some of its sales
operations, looking to external sales forces and agreements with large
regional reference laboratories.
"We are in late-stage discussions
with several [reference labs], and an agreement is eminent," she said.
She noted, however, that the company was "not looking to repeat Quest."
"We
want to make sure that we are with a consultative sales force. We want
to make sure that we are getting the proper traction and are with the
right players," she said, adding that as part of such an arrangement the
company will "implement specialized training programs" for their
partners.
Vermillion currently has 11 internal salespeople who
Palmieri said are focused on markets where the company has strong
support from key opinion leaders and positive medical coverage. She said
it plans this year to add to its sales force, either internally or
externally.
Vermillion is also continuing work to establish its
pelvic mass registry, which is key to its plans to expand its tests into
additional conditions and intended uses. According to Munroe, the
company has finalized a study protocol under which it will follow women
from the initial identification of a pelvic mass through surgery,
diagnosis, and 12-month follow up. It plans to enroll its first patient
in the third quarter and have at least 100 patients enrolled by the
year's end, he said.
The registry figures in the latest of
Vermillion's initiatives, the effort, which Palmieri announced on this
week's earnings call, to offer research services out of Aspira with the
ultimate aim of moving into the companion diagnostics business. She
declined to go into specifics, noting that it was still early days for
the effort, but said the company believed it could leverage its
expertise and clinical assets such as the registry, which Vermillion
expects will enable research into a range of gynecologic conditions, to
gain a foothold in this space.